1. *Continue on SAE supplemental page CTT21 A if more space is required
Serious Adverse Event (SAE) Report
Patient initials
Patient ID
Page 1 of 3
SAE ID
Please indicate whether it is a SAE or SUSAR being reported:
SAE
SUSAR
EudraCT Number:
Sponsor ID:
Source of report: Clinical Trial
Report Type: Initial Follow-up Country:
a) Patient data
a5) Date of Birth
a2) Gender:
a3) Height cm
a4) Weight kg
d d m m y y y y
a1) Age (yrs)
b) Serious adverse event information
b1) Date of onset of first sign/symptom of SAE
d d m m y y y y
b2) Date of awareness
d d m m y y y y
b3) SAE in medical terms (diagnosis, if possible)
b4) Case description of the above SAE (including signs/symptoms, treatment, course/outcome and suspected cause of the SAE)*
c) Seriousness criteria
c1) Patient died
c5) Congenital anomaly/birth defect
c2) Life threatening
c6) Surgical/medical intervention to prevent one of the above (if yes, please briefly outline below:)
c3) Persistent or significant disability/incapacity
c4) Involved/prolonged in-patient hospitalisation
d) Outcome at the time of this report
d1) Recovered Date of recovery
d d m m y y y y
d3) Not Recovered
d2) Recovering
d5) Fatal
Was a post-mortem undertaken?
Yes No
Was the SAE ongoing at time of death from other cause?
d d m m y y y y
d4) Recovered with sequelae
e1) Please enter details of any “relevant” prior diseases the patient has suffered that are not being treated by the study medication.*
e) Patient’s medical history
Name of conditions. (Continue if necessary on a separate sheet) a.
Start
d d m m y y y y
End
d d m m y y y y
Ongoing b.
Start
d d m m y y y y
End
d d m m y y y y
Ongoing
e2) Please enter details of any concomitant medication the patient has taken in the last 3 months*
Name of drugs, (if more than 2 drugs please add separately)
d d m m y y y y
Start
End a. b.
Page completed by________________________________
Date form completed
d d m m y y y y
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2. *Continue on SAE supplemental page CTT21 A if more space is required
Serious Adverse Event (SAE) Report
Patient initials
Patient ID
Page 2 of 3
SAE ID
f) IMP information
f1) Initial trial medication*
Initial trial medication
Date of initial dose
Trial dose /units
Route
Frequency
Drug name:
d d m m y y y y
d d m m y y y y
d d m m y y y y
f2) Trial medication at the time of the SAE*
Trial medication
Date most recent dose
Most recent trial medication:
Action taken
Date treatment stopped
(if applicable)
Drug name:
Treatment delayed
Treatment Stopped
Dose / Units
Route
None
Dose Reduction*
*% Decrease
Frequency
d d m m y y y y
d d m m y y y y
d d m m y y y y
d d m m y y y y
d d m m y y y y
d d m m y y y y
g) Treatment for the SAE
g1) Was treatment given for the SAE?*
Yes (please give details)
No (go to Section h)
Name of the treatment
Dose
Units
Route
Frequency
Page completed _________________________________
Date form completed
d d m m y y y y
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3. *Continue on SAE supplemental page CTT21 A if more space is required
SAE ID
Serious Adverse Event (SAE) Report
Patient initials
Patient ID
Page 3 of 3
h) Relevant Diagnostic Tests
h1) Are there any test / laboratory findings to record?*
No (go to Section i)
Yes (please give details)
Diagnostic test name
Date
Test value
Test units
d d m m y y y y
d d m m y y y y
d d m m y y y y
d d m m y y y y
i) Causality and Expectedness
No (go to i2)
i1) Is the SAE suspected to be related to the study treatments?
Yes
Expectedness
Expected
Unexpected (= SUSAR)
Trial treatment name
i2) If no, what is the most likely cause?
Disease (name)
Other illness (specify)
Other (specify)
Concomitant medication (specify medication)
THE SAE MUST BE REVIEWED AND THIS SECTION COMPLETED BY THE INVESTGATOR OR AN AUTHORISED, CLINICALLY QUALIFIED DELEGATE.
Refer to the SPC / IB containing the trial’s Reference Safety Information
Name _________________________________
Position _______________________________
Signature______________________________
_________________________________
Address _____________________________
_____________________________
Tel. No. _____________________________
Date ______________________________
j) SUSAR Confirmation by Chief Investigator
All suspected SUSARS must be reviewed by the CHIEF INVESTIGATOR.
Chief Investigator signature to confirm formal review of this event as a SUSAR
Date
Signed
Please note:
All suspected SUSARs MUST be sent to the sponsor within 24 hours of awareness for reporting to the regulator even if the CI is not available.
CI review can take place after this time and a SUSAR can be downgraded at a later date.
THE SPONSOR WILL REPORT SUSARS TO THE MHRA & REC.
all follow up information for SUSARs to the Sponsor as soon as possible.
Page completed _________________________________
Date form completed
d d m m y y y y
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PLEASE SAE REPORTS TO THE SPONSOR within 24 hours of becoming aware of the SAE
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